Staff Writer

Even before the 70th annual scientific sessions of the American Diabetes Association (ADA) kicked off on Friday, it was shaping up to be a big month for diabetes news.

Just last week, Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals Inc. subsidiary signed two diabetes deals: a $330 million discovery deal with Metabolex Inc. aimed at novel targets for Type II diabetes, and a $625 million marketing deal with Diamyd Medical AB for its Phase III recombinant glutamic acid decarboxylase-65 (rhGAD65) antigen-based immunotherapy to treat and prevent type 1 diabetes. (See BioWorld Today, June 23, 2010.)

The week before that, Boehringer Ingelheim GmbH ponied up $235 million in a deal with Neurocrine Biosciences Inc. to discover and develop small-molecule GPR119 agonists for Type II diabetes, among other indications. And earlier in the month, Forest Laboratories Inc. signed a whopping $1.1 billion partnership with TransTech Pharma Inc. for a portfolio of preclinical and Phase I glucokinase activators (GKAs). (See BioWorld Today, June 9, 2010, and June 18, 2010.)

Amid this flurry of diabetes deal making came ADA, releasing a flood of new diabetes data that will no doubt drive the next wave of partnering activity in the space. But one of the top highlights of ADA has been the O.K. Corral-style shoot-out between glucagon-like peptide-1 (GLP-1) agonists, most of which are already in the hands of big pharma.

Already on the market are twice-daily Byetta (exenatide, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.) and once-daily Victoza (liraglutide, Novo Nordisk AS). A once-weekly formulation of Byetta, dubbed Bydureon (exenatide LAR), got a complete response letter in March citing labeling and manufacturing issues, and is now back under review with an Oct. 22 PDUFA date. (See BioWorld Today, March 16, 2010.)

Plenty of ADA presentations are focused on Victoza and Bydureon, as well as once-weekly GLP-1 competitor taspoglutide (Ipsen SA and Roche AG). While the drugs have held up well against other diabetes staples like dipeptidyl peptidase-4 (DPP-4) inhibitor Januvia (sitagliptin, Merck & Co. Inc.), analysts are eager to handicap how they compare to each other.

Piper Jaffray & Co. analyst Ian Somaiya wrote in a research note that taspoglutide does not appear to stack up well against Bydureon. He cited taspoglutide's less impressive HbA1c reduction and higher nausea-related drop out rates. ADA data will continue to trickle out through Tuesday, but thus far, things "do not bode well for taspo and support Bydureon's best-in-class profile," he said.

Amylin got another boost just before ADA as Ipsen and Roche reported that higher-than-expected hypersensitivity reactions with taspoglutide had prompted them to amend their Phase III program and include a risk-mitigation plan, as well as add more purification steps during manufacturing - all of which are expected to set the drug back by a year. (See BioWorld Today, June 21, 2010.)

But it hasn't been all roses for Bydureon this month. Data from the DURATION-4 study showed that while the drug outperformed Januvia in reducing HbA1c, it just about tied with Takeda Pharmaceutical Co. Ltd.'s thiazolidinedione Actos (pioglitazone) and good old fashioned generic metformin. Weight loss was tied with metformin as well, although it beat the other two. (See BioWorld Today, June 16, 2010.)

And there's other GLP-1 competition coming down the pike. Also featured at ADA are Eli Lilly's once-weekly LY2189265, GlaxoSmithKline plc's once-weekly Syncria (albiglutide), Versartis Inc.'s once-monthly VRS-859, and Zealand Pharma AS/Sanofi-Aventis Group SA's once-daily lixisenatide.

The other big topic at ADA this year is obesity. Vivus Inc.'s Qnexa (phentermine/topiramate CR), Orexigen Therapeutics Inc.'s Contrave (bupropion SR/naltrexone SR) and Arena Pharmaceuticals Inc.'s lorcaserin all are under FDA review, and all have data at ADA. Vivus' Qnexa goes before an FDA advisory panel next month and may provide a first look at how the agency views this new generation of weight loss drugs.